Is Nutem Custom Manufacturing Ltd. FDA approved?

Nutem Custom Manufacturing Ltd. holds 1 FDA-registered establishment in Canada. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Nutem Custom Manufacturing Ltd.'s drugs manufactured?

The FDA register lists Oakville. Registered operations: active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Nutem Custom Manufacturing Ltd.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: Canada

Authorisation

Registered operations

Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Nutem Custom Manufacturing Ltd.	549 Great Lakes Blvd Unit 100, Oakville, Ontario L6L 0C4, Canada (CAN)	Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3037008834243333687

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Common questions

Is Nutem Custom Manufacturing Ltd. FDA approved?: Nutem Custom Manufacturing Ltd. holds 1 FDA-registered establishment in Canada. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Nutem Custom Manufacturing Ltd.'s drugs manufactured?: The FDA register lists Oakville. Registered operations: active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.